| Thursday, November 19, 2009
ScinoPharm Announces SafeBridge Potent Compound Safety Certification
ScinoPharm, a leading global supplier of active pharmaceutical ingredients (APIs), announced that its Tainan facility has received the Potent Compound Safety Certification from SafeBridgeŽ Consultants, Inc. The Certification confirms ScinoPharm’s competency and proficiency in the safe handling of potent active pharmaceutical ingredients (APIs), and applies to specific laboratories and production areas used for the manufacturing and handling of potent compounds.
ScinoPharm is the first API company in Asia to receive the industry-respected Certification, and joins six other facilities in the United States and Europe actively involved in the SafeBridge Potent Compound Safety Certified program to date.
"The Certification demonstrates our company’s commitment to maintaining international standards. Not only are our plants cGMP certified, our stringent enforcement of environmental, health and safety codes are rarities in Asia,” said Dr. Jo Shen, President and CEO of ScinoPharm.
The SafeBridge Potent Compound Safety Certification program is the most widely accepted industry benchmark for handling highly potent pharmaceuticals. SafeBridge conducted a 60-element review of programs, procedures, containment and control of the active pharmaceutical ingredients at the company’s site. Elements of the program include on-site assessment of the potent compound manufacturing and laboratory areas and the associated equipment, training, toxicology and industrial hygiene support. This third party certification covers facilities, containment equipment, procedures and personnel training concerning potent compound production operations only at ScinoPharm’s facility in Tainan, Taiwan.
ScinoPharm has over twelve FDA approved, independent production lines with separate air handling systems. Some of the lines are reserved for non-cytotoxic (lower potency) compounds. Facilities not destined for handling high potency products were not part of the Certification program.
With a cGMP manufacturing facility specifically designed to manufacture cytotoxic and high potency compounds, ScinoPharm can readily handle a range of oncology and hormonal products, as well as most other APIs made of small molecules, peptides and nucleic acids in its other production lines. The company’s competency in safely handling of materials spans from early phase clinical supplies to large-scale manufacturing for commercial launch.
About ScinoPharm Taiwan
ScinoPharm Taiwan, Ltd. is a leading process R&D and API manufacturing service provider to the global pharmaceutical industry. With cGMP production facilities, ScinoPharm offers a wide portfolio of services ranging from custom synthesis for early phase pharmaceutical activities to brand companies as well as APIs for the generic industry. Combining cost-effective resources and productivity of Asia along with extensive regulatory know-how, ScinoPharm is uniquely positioned to serve global pharmaceutical R&D and manufacturing needs at any level and for any company in this sector. For more information please visit http://www.scinopharm.com.
Media Contact:
ScinoPharm Taiwan, Ltd.
http://www.scinopharm.com
Sabrian Wu
Tel: +886-6-508-2869
Email: sabrina.wu@scinopharm.com.tw
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